U

P‑R‑O‑C‑E‑E‑D‑I‑N‑G‑S

(8:05 a.m.)

CALL TO ORDER

EXECUTIVE SECRETARY KRAUSE: Good morning everybody. If we could have everybody find a chair? We're trying to get the speakers. There are still some speakers outside. And it's the staff trying to get them in. So we may have to wait a little bit later, but I think we'll go ahead and get started now. And then if everybody's not quite ready, we'll just hold up a few minutes. But I think we'll get the meeting started so that we can at least try to keep close to schedule.

Good morning, everyone. We're ready to begin the 66th meeting of the General and Plastic Surgery Devices Panel. My name is David Krause. I'm the Executive Secretary of this panel. And I'm also a biologist and a reviewer in the Plastic and Reconstructive Surgery Devices Branch in the Division of General, Restorative, and Neurological Devices.

I'd like to remind everyone that you are requested to sign in on the attendants' sheets, which are available at the tables by the doors just outside. You may also pick up an agenda, a panel member roster, and information about today's meeting out there on the tables.

The information includes how to find out about future meeting dates through the advisory panel phone line and how to obtain meeting minutes or transcripts.

Before I turn the meeting over to Dr. Choti, I'm required to read a statement into the record regarding conflict of interest.

CONFLICT OF INTEREST AND OPENING REMARKS

EXECUTIVE SECRETARY KRAUSE: "The following announcement addresses conflict of interest issues associated with this meeting and is made a part of the record to preclude the appearance of an impropriety.

"To determine if any conflict existed, the agency reviewed the submitted agenda for this meeting and all financial interests reported by the committee participants.

"Conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests. However, the agency has determined that participation of certain members and consultants, the need for whose services outweigh the potential conflict of interest involved, is in the best interest of the government.

"We would like to note for the record that the agency took into consideration certain matters regarding Dr. Miller. Dr. Miller reported his institution's past and current involvement with firms at issue.

"In the absence of personal financial interest, the agency has determined that he may participate fully in the panel's deliberations. In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, a participant should excuse him or her self from such involvement. And the exclusion will be noted for the record.

"With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon."

At this point I'd like to turn the meeting over to Dr. Choti, the chairman.

CHAIRMAN CHOTI: Thank you, Dr. Krause, and good morning.

My name is Dr. Michael Choti. I'm in the Division of Surgical Oncology at Johns Hopkins University. And I am the standing chair of this panel.

During this three‑day meeting, we, our panel, would like to make recommendations to the Food and Drug Administration on two pre‑market approval applications.

PANEL INTRODUCTIONS

CHAIRMAN CHOTI: The next item of business is to introduce the panel members, who are giving their time to help the FDA in these matters and the FDA staff here at the table. I'm going to ask each person to introduce him or herself, starting with both the area of expertise, position title, institution, and his or her status on the panel, either voting member or industry. Let me start on the left side of the panel here with Dr. Bartoo.

MEMBER BARTOO: My name is Grace Bartoo. I'm the General Manager of Decus Biomedical. I have experience in biomedical engineering. That's what my training is in. But I also have a lot of experience in clinical trials and medical advice research.

I am the industry representative for the panel.

MEMBER DOYLE: My name is LeeLee Doyle. I have a Ph.D. in reproductive physiology. I am a Professor Emeritus of Obstetrics and Gynecology and currently the Assistant Dean for Faculty Development at the University of Arkansas for Medical Sciences College of Medicine.

I am the consumer representative, a nonvoting member.

MEMBER BLUMENSTEIN: My name is Brent Blumenstein. I am a biostatistician. I work independently from Seattle, Washington.

MEMBER EWING: My name is Cheryl Ewing. I am a faculty member at the University of California at San Francisco in the Department of Surgery in surgical oncology with a specialty in breast oncology.

MEMBER NEWBURGER: I'm Dr. Amy Newburger. I'm a dermatologist in private practice, Director of Dermatology Consultants of Westchester. I teach at St. Luke's‑Roosevelt Hospital Medical Consortium.

MEMBER LoCICERO: I'm Joseph LoCicero. I'm a thoracic surgeon specializing in foregut surgery. I'm Professor and Chair of Surgery at the University of South Alabama.

And I am a voting member.

MEMBER MANNO: I'm Dr. Barbara Manno. I am a toxicologist. I'm a professor with the Department of Psychiatry at the Louisiana State University Health Sciences Center in Shreveport, Louisiana and voting today.

MEMBER LI: My name is Steve Li. I am the President of Medical Device Testing and Innovations in Sarasota, Florida. My areas of expertise are biomechanics and biomaterials.

And I am a voting member today.

EXECUTIVE SECRETARY KRAUSE: My name is David Krause. I am the Executive Secretary.

MEMBER CALLAHAN: I'm Leigh Callahan. I'm a health outcomes researcher, an epidemiologist at the University of North Carolina in Chapel Hill. I'm in the Departments of Medicine and Orthopedics.

And I am a temporary voting member for this panel.

DR. MILLER: I'm Michael Miller. I am Professor and Deputy Chairman of Plastic Surgery at University of Texas, M. D. Anderson Cancer Center.

My clinical work involves cancer‑related reconstructive surgery. I also have appointments in biomedical engineering with the University of Texas Center for Biomedical Engineering and at Rice University.

MEMBER LEITCH: I'm Marilyn Leitch. I'm a surgical oncologist at the University of Texas Southwestern Medical Center in Dallas. I also am involved primarily in the treatment of breast cancer patients but do see patients with benign diseases as well. And I am a professor of surgery.

DR. PROVOST: I'm Miriam Provost. I am Acting Director for the Division of General, Restorative, and Neurological Devices in the Office of Device Evaluation at FDA.

EXECUTIVE SECRETARY KRAUSE: Let me just clarify for the record that Drs. Leitch, Miller, LoCicero, Newburger, Ewing, and Blumenstein are all voting members on this panel. Drs. Manno, Li, and Callahan are deputized voting members. And we will read the deputization memo tomorrow.

CHAIRMAN CHOTI: I would like to note for the record that the voting members present constitute a quorum, as required by 21 CFR Part 14.

Let me read a letter from Dr. Michael Olding, who was to be a member, a nonvoting member, on this panel. He elected not to be present and requested that the following letter be read, "Dear Dr. Choti, I would like to request the following statement to be read into the record at the time of the General and Plastic Surgery Panel meeting.

"On December 2004, I agreed to serve on this panel with great enthusiasm for its mission and with a full understanding of the commitment and the need for impartiality. Accordingly, I completed the required conflict of interest statement in January 2005, indicated that there are no conflicts.

"Subsequently, on March 21st, 2005, Medicus Pharmaceutical Corporation announced plans to merge with Inamed Corporation, a firm at issue. That merger is subject to approval by stockholders, regulatory approvals, and customary closing conditions according to the companies.

"Upon learning of the planned merger, I immediately notified the Executive Secretary of the proposed merger and that I owned a quantity of stock in Medicus.

"Initially, on April 1st, 2005, the Executive Secretary indicated that my service on the panel would not be affected by my stock holdings and the planned merger, but one business day before this meeting, on Friday, April 8th, I received a fax from Integrity Committee and Conference Management Branch informing me that due to the stock‑holding value, between 50,000 and 100,000, in a firm that is slated to merge with a firm at issue, I would be excluded from voting on the panel. It does appear that I would be allowed to 'review and discuss matters before the panel,' even though I am denied the right to vote.

"As the chronology demonstrates, the incipient conflict was created by the decision of the two companies to merge and not by any action on my part. Indeed, I made the FDA aware of the situation.

"I was fully prepared and committed to continuing my service on the panel impartially and a relatively small stock‑holding I have in the company, which until March 2005 had no interest in the outcome of our work, would have no bearing on my decision‑making process.

"I do not feel it is appropriate for me to continue my service on the panel as a partial member; that is, one without voting rights. Since the FDA has concluded that my voting may create an appearance of a conflict due to my stock holdings, I do not want my continued service as a nonvoting panel member to be suspect in any way.

"I regret having to make this decision as I possess important experience as a plastic surgeon for the panel to consider. And my departure will leave only one other professional with similar experience. But the handicap that the FDA has placed upon me because of the incipient conflict, not of my making, that arose since my appointment to the panel makes my decision necessary.

"Thank you for your consideration and understanding. And good luck to you and the panel in your important work. Sincerely, Michael Olding."

Now I would like to introduce Commander Stephen Rhoades, the Acting Deputy Director of the Division of General, Restorative, and Neurological Devices, who will update the panel since the last meeting.

Dr. Rhoades?

CDR RHOADES: Thank you, Dr. Choti.

PANEL UPDATE

CDR RHOADES: I am Stephen Rhoades. I am the Acting Deputy Director in the Division of General, Restorative, and Neurological Devices. Welcome, members of the panel, members of the public, and manufacturers, to this important three‑day meeting of the General and Plastic Surgery Devices Panel on two silicone gel‑filled breast implants.

Tomorrow you will make recommendations and vote on Inamed Corporation's pre‑market approval application. On Wednesday, you will make recommendations and vote on Mentor Corporation's pre‑market approval application.

Because of the high public interest in silicone gel‑filled breast implants, in addition to the regular public comment periods for any PMA discussion, we have scheduled a full day for a public comment on issues related to silicone gel‑filled breast implants.

This panel last met on March 25th of 2004, at which time you recommended approval of Dermik Laboratories pre‑market approval application for their Sculptra dermal filler for lipoatrophy in HIV‑positive patients. This device application was approved on August 3rd with a conditional post‑approval study to evaluate long‑term safety.

On April 22nd of 2004, FDA approved Genzyme Corporation's Hylaform dermal filler for moderate to severe facial wrinkles and folds.

This panel recommended approval of this device at the November 21st, 2003 panel meeting. The approval included a condition for a post‑approval study in patients with Fitzpatrick IV to VI skin types.

On August 9th, 2004, FDA issued a final rule classifying silicone sheeting for the management of closed hyperproliferative scars as Class I devices exempt from pre‑market notification. This panel recommended that these be Class I‑exempt at the July 24th, 2003 panel meeting.

The agency appreciates the commitment of the panel members. And we also appreciate the comments of the representatives of the 30 professional organizations and 145 members of the public who have requested time to address the panel today.

Thank you for your attention. I would now like to introduce Dr. Miriam Provost for a few words.

WELCOMING REMARKS

DR. PROVOST: Good morning. As Commander Rhoades said, I am Miriam Provost. I am the Acting Director for the Division of General, Restorative, and Neurological Devices.

I would like to just take a few minutes and give everyone a brief regulatory background followed by a discussion of why we have convened this meeting and what are we asking you, our distinguished advisory panel, to do.

First, some background on the regulatory status of silicone gel‑filled breast implants. Prior to 1991, silicone gel‑filled breast implants were sold on the market either as pre‑amendments devices, which means they were on the market prior to May 1976, or as a 510(k)‑cleared device.

In April 1991, FDA issued a regulation that required all manufacturers of silicone gel‑filled breast implants to submit safety and effectiveness data in PMAs in order for their products to remain on the market.

Several PMAs were submitted and presented to an advisory panel in November 1991 and then again in February 1992. In April 1992, FDA determined that the PMAs did not include adequate safety data to support approval. However, at the same time, FDA believed there was a public health need to have breast implants available for reconstruction in revision patients.

In 1992, because FDA believed it was important to provide continued availability of silicone gel‑filled breast implants for women seeking breast reconstruction or revision, we developed a new type of study design referred to by industry and the FDA as an adjunct study.

Inamed in 1998 and Mentor in 1992 are the only two companies that have received FDA approval for an adjunct study. Inamed's and Mentor's adjunct studies currently remain active. Both adjunct studies require five‑year follow‑up for each patient enrolled. And there is no limit on the enrollment of reconstruction or revision patients or on the number of investigational sties.

Adjunct studies are focused on the collection of safety data and do not include MRIs screening for silent rupture. The 1992 agreements between FDA and industry also described information to be collected in the study design to evaluate safety and effectiveness to support a PMA, the so‑called "core study."

The investigational device exemption, or IDE, studies are the mechanism by which the core study data, which you will hear referenced during this panel meeting, are collected.

Inamed submitted and received approval for their core study in 1998. Mentor submitted and received approval for their core study in 2000.

At the current time, FDA has not approved any PMAs for silicone gel‑filled breast implants. They remain investigational devices, which means that a patient must be enrolled in an adjunct study or an IDE study in order to receive one of these implants in the U.S.

I'd also like to note that in January 2004, FDA issued a draft update of our guidance document for manufacturers of breast implants. This document is a framework for breast implant manufacturers. And it includes recommendations on the kind of information that FDA recommends be provided in a PMA.

We have received numerous comments on the draft guidance. And at the present time, we are continuing to review the comments that we received. Once we have reviewed the comments and made revisions, as appropriate, the guidance document will be released in final.

It should be emphasized that our review of the information in a PMA is not affected by whether a guidance document for the product in question is in draft or final form. As is the case for all medical device applications, FDA will base our decisions on the scientific and clinical data in the PMAs as well as the panel's deliberations and recommendations regarding those data.

Now for the task at hand. Inamed's PMA, P020056, was presented previously at the October 2003 meeting of the General and Plastic Surgery Devices Advisory Panel. The panel recommended in a nine to six vote that the PMA was approvable with conditions.

In January of 2004, after considering the data in the PMA and the panel's deliberations of the data, we determined that the PMA was not approvable because the data did not provide a reasonable assurance of safety for the device.

Therefore, FDA's presentation at this panel meeting for the Inamed PMA will focus on the additional information submitted by Inamed to address the outstanding safety issues. The Inamed PMA will be the panel's focus on Tuesday.

Mentor's PMA, P030053, is being presented for the first time at a panel meeting. Therefore, FDA's presentation for this PMA will involve a summary of all relevant preclinical and clinical data. The Mentor PMA will be the panel's focus on Wednesday.

It should be noted that, although the core study is the primary source of clinical data for both PMAs, both sponsors use data and information from multiple sources to address the key safety issues.

Based on your own scientific and clinical knowledge, we are asking you, the panel, to discuss the data in each individual PMA and advise us as to whether there is sufficient information to provide a reasonable assurance of safety and effectiveness for each device.

After the panel meeting, FDA will continue to review the information contained in this PMA. We will carefully consider the deliberations and recommendations that you make during this meeting. Ultimately FDA will make a decision on the approvability of these two PMAs.

We will also hear a number of comments from the public today as well as on Tuesday and Wednesday. And I want to thank the members of the public for making the effort to come here today to present their views on these applications.

I want to assure everyone that the FDA will carefully listen to these comments. And, as previously stated, we will make our decision based on the scientific data in the PMAs and the panel's deliberations on the data.

I do want to remind everyone, however, that this meeting is not intended as a general referendum on silicone gel‑filled breast implants. This panel meeting focuses specifically on the safety and effectiveness of two individual breast implant PMAs. And the object of this meeting is to obtain input from you, the panel, on the data in these applications. The FDA is very appreciative of your giving of your time and expertise to accomplish this important task.

Thank you very much. And now I'm going to turn it back over to you, Dr. Choti.

CHAIRMAN CHOTI: Thank you, Dr. Provost.

We will now proceed with the open public hearing session of this meeting. All persons addressing the panel are asked to speak clearly into the microphone as the transcriptionist is depending on this as a means to accurate recording of the meeting.

I would like to have the attention of all of the individuals who are registered to speak to the panel today. You have been given a number of correspondence regarding the order of your appearance.

Please come to the podium area in advance so that we are not spending a great deal of time in transitions from speaker to speaker. And we have two podiums set up in order to alternate and for time sake. The FDA panel will direct you to the appropriate podium.

Please remain within your time constraints as a timer will be present to help you with this. We have many public speakers today. And so it is extremely important that we stay on time.

There is a yellow light that will flash 30 seconds before your time is up. And the red light flashes as soon as your time is up. If you're still speaking at that time, then I will promptly instruct you to summarize and cut off. If after ten seconds that is not done, then I have been told that the microphone will be cut off. So please try to stay to your allotted times.

Also, regarding your written comments, please only bring to the panel your written comments that have been submitted or your presentation slides. No additional material, please.

We would also like to address the issue of financial disclosure. Before the Food and Drug Administration and the public believe in transparent process for the information gathering and decision‑making, to ensure such transparency at the open public hearing session of the Advisory Committee meeting, the FDA believes it is important to understand the context of an individual's presentation.

For this reason, the FDA encourages you, the open public hearing speaker, at the beginning of your written or oral statement to advise the Committee of any financial relationship you may have with the sponsor; its product; and, if known, its direct competitors. For example, this financial information may include the sponsor's payment for your travel, lodging, or other expenses in connection with your attendance at the meeting. Likewise, the FDA encourages that you at the beginning of your statement advise the Committee if you do not have such financial relationships.

If you do not choose to address this issue of financial relationships at the beginning of your presentation, it will not preclude you from speaking.

Let's begin with the first speaker. These individuals are the ones who have notified the FDA of their intent to testify during the open public session.

The first speaker, please? Thank you. Good morning.

MS. JOHNSTON: Thank you.

OPEN PUBLIC COMMENT

MS. JOHNSTON: Good morning. My name is Kathy Keithley Johnston. I'm the Executive Director and founder of Toxic Discovery, a national not‑for‑profit consumer advocacy organization. I am also a registered nurse. And I myself used to have silicone gel breast implants. I have no conflicts of interest.

I am here today carrying the voices of thousands who have been directly affected by the failure of the FDA to require long‑term safety studies concerning breast implants.

We believe the FDA made the right decision in 2004 when they decided not to approve Inamed's silicone breast implants. The new guidance that the FDA issued at the same time was an important step forward, demonstrating the FDA's commitment to assure that breast implants are safe for long‑term health studies before they allow them to be widely sold.

I am here today counting on you to help the FDA to adhere to the guidance document. Silicone breast implants should not be approved until a company can prove the safety of devices for long‑term use. Since safety cannot be proven, we ask you to deny the manufacturer's application.

Implant lobbyists claim that there are over 100 studies of women with implants that show no evidence of harm. That is clearly and absolutely false. These groups conveniently ignore the following studies: a study by the FDA of women with silicone breast implants that at least found for six years that women had at least one failed breast implant, even though they did not know it. This is referred to as a "silent rupture."

That same study found that 21 percent had silicone leakage outside the scar capsule surrounding their implant. From there, silicone could harm breast tissue, could migrate into lymph nodes and, thereby, travel to lungs, liver, or other vital organs.

The FDA also found that women with leaking silicone breast implants were more likely to report fibromyalgia and other connective tissue diseases. Scientists at the National Cancer Institute found that women having breast implants for at least seven years were twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide compared to other plastic surgery patients.

A Canadian study found that women with breast implants for augmentation were more likely to be hospitalized and had more physician visits than women of the same age living in the same communities.

These are just a few of the studies that were a serious concern about risk of silicone leakage. Research has not yet been done to determine exactly what chemicals leak into a woman's body and what long‑term health consequences then results from that leakage and migration of silicone. How can informed consent be obtained when information is not even known by the very physician implanting these risky devices?

Neither Inamed nor Mentor has conducted studies of the health impact of leaking silicone in a woman's body. Dow‑Corning has funded one such study. In a Danish study, Holmich claimed that leakage was not significantly related to connective tissue disease. However, there were only 23 women in this study with extracapsular leakage, a sample that is much too small to provide meaningful safety data. In fact, the study showed that women were four times as likely in that study to report a connective tissue disease compared to women whose implants were not ruptured. But these impressive differences were not statistically significant because the sample was too small.

You would certainly think after 40 years that implant manufacturers should find more than 23 women with extracapsular rupture. Without a doubt, there are more than 40 in this very room today. There are hundreds of thousands of women in this nation whose body would show you that leakage is present if testing was provided.

Our organization has serious concerns about the integrity of the studies conducted by Inamed and Mentor. Patients in these studies have informed us of their fears that they believed that their problems with implants were never reported by their physician or the manufacturer.

In closing, let me remind you of the duties of the FDA. First and foremost, the FDA is a public health agency charged with protecting American consumers. The FDA should be the consumer watchdog and not the advocate of the breast implant manufacturer.

It is your job to make sure that the FDA protects patient safety concerning breast implants. This can only be done by requiring long‑term health studies before approval and not after approval.

It is certainly not your job to protect the livelihood of plastic surgeons or implant makers. Both have failed in their promises to protect women, which will not make the situation better. It will only allow it to continue. And we ask you, please protect the women of this nation.

CHAIRMAN CHOTI: Thank you.

Next speaker?

MS. GROSS: Good morning, panel. I am Marcy Gross. I am a consultant who specializes in women's health issues. I am a member of the State of Maryland Women's Health Promotion Council and serve on the boards of various private health organizations.

Prior to becoming a consultant, I worked for the Department of Health, U.S. Department of Health and Human Services, where I was a Senior Policy Analyst for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior Adviser for Women's Health at the Agency for Healthcare Research and Quality, where I served while there on the secretarial ad hoc task force on silicone breast implants.

I give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private citizen. I have no financial links to any of the applicants.

A legacy from my six‑year tenure at AHRQ is an appreciation of the need for a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long‑term gold standard study that will produce independent, objective research findings seems not to be on the horizon.

We do have 40 years of experience with breast implants, including 25 years when the silicone implants were available to women, all women. They were pulled from the market for good reason. They were associated with major medical problems.

The basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health aspects of silicone gel implants are still short‑term and are often produced by companies that manufacture the devices or materials.

Second, the work that is available, some from FDA itself, indicates that the rate of complications of implantation, reinfections, reoperations, and other adverse events are sufficiently high to remain a major concern, despite advances in materials.

Third ‑‑ and this is a change from the past ‑‑ the Mentor applicant agrees that the devices will not last indefinitely and warned women that they should expect to have them replaced. So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after or the reverse?

Letting women be living testers I find highly objectionable since these are elective procedures and there are alternatives, especially since the data on improvements in the quality of life for patients undergoing implantation are weak by accepted research standards and most especially since it is expected the devices will fail and will have to be removed.

On this last point, the overall failure rate, it should be noted that Mentor acknowledges that their devices will have a finite in vivo life, which means, really, that all will fail and need to be surgically removed. We just don't know when.

I would assert that if this were an NIH‑funded research study, it's unlikely it would go forward.

CHAIRMAN CHOTI: Please sum up for us.

MS. GROSS: Yes, please. I just ask that you have the data in hand before you reintroduce the silicone breast implants. Thank you for your time.

CHAIRMAN CHOTI: Thank you.

Let me remind the audience that speakers have three minutes unless it's a national organization. And then it's five minutes.

Yes, next speaker?

MR. SCHULTZ: Good morning. My name is William Schultz. I am representing a group of women's organizations led by Command Trust. I appreciate being given five minutes. Thank you.

Thank you for the opportunity to address this Committee on the very important question of whether FDA should approve the applications for silicone gel breast implants. For the record, I have no financial ties to either of the applicants.

Congress enacted the medical device amendments in 1976 in the wake of several tragedies, including the Dalkon shield IUD, which killed 16 women and injured countless others. Congress sought to remedy the defect by a new law, the defect being that medical devices were being marketed without any demonstration of their safety or any adequate testing.

Congress was particularly concerned about the safety of implantable devices. The basic showing that it required manufacturers of these devices to make was that there was a reasonable assurance that the device was safe and effective. In the case of breast implants, efficacy is obviously not the issue. Instead, the issue is safety.

If you think about it, for a therapeutic product, such as a heart valve, the safety standard entails a weighing of risk versus benefits to health. And so FDA may approve a product with substantial risks if it finds the benefits are even greater.

But for a cosmetic product, which is what we have before us today, there are no therapeutic benefits. For these products, the law does not allow approval if the product is associated with significant risk or even if there is significant uncertainty about safety. And I think that is a very important principle to keep in mind as we go through the next three days.

It is also relevant that the manufacturer has the burden of proof. Where there are doubts or uncertainties, then the product may not be approved because the manufacturer has not carried its burden. The law does not contemplate that the patients or consumers should bear the risk of unanswered questions.

At the October 2003 Advisory Committee meeting, there was discussion of various approval conditions and post‑market studies. First, the Committee should understand that any approval conditions are not enforceable by FDA. Once the agency approves a product, then physicians are allowed to deviate from restrictions on the use of the product. And FDA has no authority to enforce those restrictions.

Second, while post‑market studies may be useful, they cannot substitute for the basic safety standard in the statute. The statute does not provide that the agency may approve a product now and allow the demonstration of safety at a later date.

At the last Advisor Committee meeting, there was also discussion about whether women should have the option or the choice of using breast implants as long as they were fully informed.

Although Congress has adopted the buyer beware approach for dietary supplements and in other areas, this was not the approach that it adopted for medical devices. Instead, for these products, it has declared in law that medical devices are not to be available until the manufacturer has demonstrated safety. It is this Committee's charge to do its best to apply that law.

Congress' approach has two important benefits. First, it means that patients and consumers can be confident of the safety of device products that they use. It also creates an important incentive to the manufacturers to design their products to meet the high standard that Congress established.

Significant questions have been raised about the safety of breast implants. I'm not going to address those. But it's important, of course. These products are going to be in the body for many years. Even though the manufacturers have known about the standards of the statute for more than 25 years, we don't really have long‑term data. And given the extremely high breakage rate of these products, lack of long‑term data raises serious problems.

In January 2004, FDA determined that the evidence was not adequate. And the question that this Committee must look at is whether the companies have produced additional data that is sufficient to justify approval.

In conclusion, approval of silicone gel breast implants without an adequate demonstration of safety would have two very unfortunate consequences. First, we would have lost the opportunity to require that these products be adequately tested.

And, perhaps even more important, such a decision would send a message to other product manufacturers that the door has been open for approval of medical devices that do not meet the safety requirements established by law and that patients will suffer.

Thank you very much. And good luck.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. HELMAN: Hi. Good morning. I'm Susan Helman from Florida. I have paid my own way here because I feel that this panel needs to hear from women like me.

I had breast implants for 15 years and suffered greatly. My implants ruptured. And after numerous surgeries to remove silicone from my body, the last surgeon stated, "There is no way to remove it all, Susan. It's migrated to all your tissues, your organs. It's everywhere." Silicone as well as platinum was found in my cheek cells, bone marrow, and lymph nodes, also in my urine and in my blood.

My urine platinum levels when measured eight years after explantation were 25 parts per billion, which is within the range of patients receiving chemotherapy agent cisplatin. The urine platinum level in the general population is .04 parts per billion. So mine was more than 500 times greater.

The platinum ion in my urine and in my tissues I found was the exact match to my implants that they studied as well. My body is full of ionized platinum with no known way to remove it.

As you know, the CDC has identified platinum as a suspected toxin. Because of my ruptured implants and the resulting exposure to silicone and platinum, I have been diagnosed with MS and lupus and fibromyalgia and scleroderma among many other things.

And I'm sick. And I can't get health insurance. When I need it the most, I can't get it. I don't want anybody else to suffer this way. I get severe disabling headaches and nausea when I am exposed to exhaust fumes or unusual odors of any kind, and I never had this problem before ever.

I'm also concerned about young women of childbearing age and their children. I've heard that platinum can be transmitted in milk. And I have platinum in my urine. So, you know, I see no reason why it couldn't be in breast milk.

Any mother would be heartbroken to find out that during a cosmetic surgery, unbeknownst to her, it caused her breast milk to be adulterated and cause injury to her newborn child.

I just ask that before implants are considered safe, platinum testing be done on a random sample of women with silicone gel breast implants and on women with implants, the breast milk of women with implants.

And, in closing, please, please, please vote against the gel‑filled breast implants until you're sure that the benefits far outweigh the risks. The first oath a doctor learns is do no harm.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. GLICKSMAN: Mr. Chairman and members of the panel, my name is Dr. Caroline Glicksman. And I am reading the testimony from my patient Valerie Hartwell, a 45‑year‑old mother of 3 who is unable to attend today because of work requirements.

"I would like to advise the Committee that I have no financial relationships with anyone connected at this meeting. I had silicone breast implants for two years. I had them put in because of a chest wall deformity I was born with that caused a considerable and noticeable depression along the sternum on my right side.

"The size of one of my breasts was considerably smaller than the other, causing me to be extremely self‑conscious my whole life. I would not wear bathing suits or shirts with a neckline lower than my collarbone because my deformity was so obvious.

"I am so thrilled that I had the silicone implant option available to me. It has made a dramatic difference in my self‑esteem. My self‑confidence has improved drastically.

"I have one anatomical implant on the defective side, which has helped with the depression along my sternum. The other implant is round, to create uniformity. I have had absolutely no side effects.

"My breasts remain soft and natural‑looking, which is very important to me. They feel natural as well. I am able to sleep comfortably in any position. I have had no problem with hardness and no dimpling.